Ibuprofen Capsule side effects: what 198,211 FDA adverse event reports show
Drug class
Nonsteroidal Anti-inflammatory Drug
Who reports
198,211 reports · 73% serious · 16,220 with death outcome · 65% female
Used for
Carefully consider the potential benefits and risks of Ibuprofen Tablets and other treatment options before deciding to use Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals . Ibuprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
What it is
Ibuprofen is a monocarboxylic acid that is propionic acid in which one of the hydrogens at position 2 is substituted by a 4-(2-methylpropyl)phenyl group.
Boxed warning
Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see WARNINGS and PRECAUTIONS ].
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,134 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Nsaid exacerbated respiratory disease | 172 | 99.9 81.0–123.1ROR 99.9 · calibrated p 2e-7 ✓ | 51.0 EB05 44.9 · IC025 +5.2 3/3 methods agree vs other NSAIDs: PRR 15.4 (13.0–18.3) | Not in label — unassessed | serious n=169 · ♀ 0% (drug 65%) · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 287 | 79.7 68.4–93.0ROR 79.8 · calibrated p 7e-7 ✓ | 45.3 EB05 41.1 · IC025 +5.2 3/3 methods agree vs other NSAIDs: PRR 5.7 (5.0–6.4) | Lab value / disease marker | serious n=287 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 797 | 72.3 66.1–79.2ROR 72.6 · calibrated p 1e-6 ✓ | 42.9 EB05 40.5 · IC025 +5.3 3/3 methods agree vs other NSAIDs: PRR 5.1 (4.7–5.5) | Not in label — unassessed | serious n=797 · ♀ 100% (drug 65%) · 91% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 2,892 | 68.6 65.5–71.9ROR 69.6 · calibrated p 2e-6 ✓ | 41.6 EB05 40.4 · IC025 +5.3 3/3 methods agree vs other NSAIDs: PRR 5.9 (5.7–6.2) | Labeled — boxed warning synonym match | serious PRR 32.8 · ♀ 96% (drug 65%) · 93% clinician | NCT00346216: 2/7,933 (0.0%) on Ibuprofen Capsule (serious AE) |
| C-reactive protein | 347 | 65.3 57.1–74.7ROR 65.4 · calibrated p 3e-6 ✓ | 40.3 EB05 36.9 · IC025 +5.1 3/3 methods agree vs other NSAIDs: PRR 4.8 (4.3–5.3) | Lab value / disease marker | serious n=347 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 2,632 | 62.1 59.1–65.1ROR 62.9 · calibrated p 3e-6 ✓ | 39.1 EB05 37.9 · IC025 +5.2 3/3 methods agree vs other NSAIDs: PRR 5.8 (5.6–6.0) | Lab value / disease marker | serious PRR 31.0 · ♀ 100% (drug 65%) · 94% clinician | not reported in cached trials |
| Lupus vulgaris | 431 | 59.9 53.2–67.4ROR 60.0 · calibrated p 4e-6 ✓ | 38.2 EB05 35.3 · IC025 +5.0 3/3 methods agree vs other NSAIDs: PRR 4.8 (4.3–5.3) | Not in label — unassessed | serious n=431 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Muscle injury | 2,935 | 58.7 56.1–61.4ROR 59.6 · calibrated p 4e-6 ✓ | 37.8 EB05 36.7 · IC025 +5.2 3/3 methods agree vs other NSAIDs: PRR 6.6 (6.3–6.8) | Not in label — unassessed | serious PRR 32.2 · ♀ 100% (drug 65%) · 92% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 193 | 57.8 48.5–68.9ROR 57.9 · calibrated p 6e-6 ✓ | 37.3 EB05 33.1 · IC025 +4.9 3/3 methods agree vs other NSAIDs: PRR 6.2 (5.4–7.3) | Not in label — unassessed | serious n=192 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 2,217 | 55.4 52.6–58.3ROR 56.0 · calibrated p 7e-6 ✓ | 36.4 EB05 35.1 · IC025 +5.1 3/3 methods agree vs other NSAIDs: PRR 6.9 (6.6–7.2) | Labeled (related wording) related wording | serious n=2,210 · ♀ 100% (drug 65%) · 93% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 689 | 54.7 49.9–60.0ROR 54.9 · calibrated p 8e-6 ✓ | 36.1 EB05 33.9 · IC025 +5.0 3/3 methods agree vs other NSAIDs: PRR 5.4 (5.0–5.9) | Not in label — unassessed | serious n=684 · ♀ 100% (drug 65%) · 93% clinician | not reported in cached trials |
| Swollen joint count increased | 1,011 | 50.5 46.9–54.5ROR 50.8 · calibrated p 1e-5 ✓ | 34.2 EB05 32.5 · IC025 +5.0 3/3 methods agree vs other NSAIDs: PRR 4.8 (4.5–5.1) | Lab value / disease marker | serious n=1,010 · ♀ 100% (drug 65%) · 95% clinician | not reported in cached trials |
| Aspirin-exacerbated respiratory disease | 196 | 48.1 40.6–57.0ROR 48.2 · calibrated p 2e-5 ✓ | 33.1 EB05 29.3 · IC025 +4.7 3/3 methods agree vs other NSAIDs: PRR 11.6 (9.9–13.5) | Not in label — unassessed | serious n=191 · 100% clinician | not reported in cached trials |
| Rheumatic fever | 1,258 | 42.6 39.9–45.5ROR 42.8 · calibrated p 4e-5 ✓ | 30.4 EB05 29.0 · IC025 +4.8 3/3 methods agree vs other NSAIDs: PRR 4.4 (4.2–4.7) | Likely indication confounding shares a disease stem with the indications wording | serious n=1,258 · ♀ 100% (drug 65%) · 94% clinician | not reported in cached trials |
| X-ray abnormal | 510 | 42.1 38.0–46.7ROR 42.2 · calibrated p 4e-5 ✓ | 30.2 EB05 28.0 · IC025 +4.7 3/3 methods agree vs other NSAIDs: PRR 5.2 (4.8–5.7) | Lab value / disease marker | serious n=510 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Dislocation of vertebra | 619 | 40.6 37.0–44.5ROR 40.7 · calibrated p 5e-5 ✓ | 29.4 EB05 27.5 · IC025 +4.7 3/3 methods agree vs other NSAIDs: PRR 5.0 (4.6–5.4) | Not in label — unassessed | serious n=619 · ♀ 100% (drug 65%) · 92% clinician | not reported in cached trials |
| Folliculitis | 2,860 | 40.3 38.6–42.1ROR 40.9 · calibrated p 5e-5 ✓ | 29.3 EB05 28.4 · IC025 +4.8 3/3 methods agree vs other NSAIDs: PRR 5.9 (5.6–6.1) | Not in label — unassessed | serious PRR 27.0 · ♀ 100% (drug 65%) · 93% clinician | not reported in cached trials |
| Helicobacter infection | 2,811 | 40.1 38.4–41.8ROR 40.6 · calibrated p 5e-5 ✓ | 29.1 EB05 28.3 · IC025 +4.8 3/3 methods agree vs other NSAIDs: PRR 5.6 (5.4–5.8) | Not in label — unassessed | serious PRR 24.3 · ♀ 100% (drug 65%) · 93% clinician | not reported in cached trials |
| Cross sensitivity reaction | 239 | 34.7 30.0–40.2ROR 34.7 · calibrated p 1e-4 ✓ | 26.2 EB05 23.5 · IC025 +4.4 3/3 methods agree vs other NSAIDs: PRR 11.4 (9.9–13.2) | Not in label — unassessed | serious n=238 · 100% clinician | not reported in cached trials |
| Rheumatoid factor positive | 1,431 | 34.7 32.7–36.8ROR 34.9 · calibrated p 1e-4 ✓ | 26.2 EB05 25.1 · IC025 +4.6 3/3 methods agree vs other NSAIDs: PRR 5.0 (4.7–5.3) | Lab value / disease marker | serious n=1,431 · ♀ 100% (drug 65%) · 95% clinician | not reported in cached trials |
| Facet joint syndrome | 742 | 32.4 29.8–35.1ROR 32.5 · calibrated p 2e-4 ✓ | 24.9 EB05 23.4 · IC025 +4.5 3/3 methods agree vs other NSAIDs: PRR 3.8 (3.5–4.1) | Not in label — unassessed | serious n=742 · ♀ 100% (drug 65%) · 92% clinician | NCT00346216: 1/7,933 (0.0%) on Ibuprofen Capsule (serious AE) |
| Pemphigus | 2,876 | 31.6 30.4–33.0ROR 32.1 · calibrated p 2e-4 ✓ | 24.5 EB05 23.7 · IC025 +4.5 3/3 methods agree vs other NSAIDs: PRR 5.5 (5.3–5.7) | Not in label — unassessed | serious PRR 19.4 · ♀ 100% (drug 65%) · 94% clinician | not reported in cached trials |
| Hand deformity | 2,789 | 28.5 27.3–29.7ROR 28.9 · calibrated p 3e-4 ✓ | 22.5 EB05 21.8 · IC025 +4.4 3/3 methods agree vs other NSAIDs: PRR 5.2 (5.1–5.4) | Not in label — unassessed | serious PRR 19.3 · ♀ 100% (drug 65%) · 92% clinician | not reported in cached trials |
| Retinitis | 335 | 26.4 23.4–29.7ROR 26.4 · calibrated p 5e-4 ✓ | 21.2 EB05 19.4 · IC025 +4.2 3/3 methods agree vs other NSAIDs: PRR 5.0 (4.5–5.6) | Not in label — unassessed | serious n=335 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| C-reactive protein abnormal | 1,230 | 25.0 23.5–26.6ROR 25.1 · calibrated p 7e-4 ✓ | 20.3 EB05 19.4 · IC025 +4.2 3/3 methods agree vs other NSAIDs: PRR 4.4 (4.1–4.6) | Lab value / disease marker | serious n=1,228 · ♀ 93% (drug 65%) · 94% clinician | not reported in cached trials |
| Pericarditis | 3,109 | 24.1 23.2–25.0ROR 24.5 · calibrated p 8e-4 ✓ | 19.7 EB05 19.1 · IC025 +4.2 3/3 methods agree vs other NSAIDs: PRR 5.6 (5.4–5.8) | Not in label — unassessed | serious PRR 15.7 · ♀ 95% (drug 65%) · 92% clinician | NCT00346216: 1/7,992 (0.0%) on Ibuprofen Capsule (serious AE) |
| Enthesopathy | 286 | 23.3 20.5–26.4ROR 23.3 · calibrated p 1e-3 ✓ | 19.1 EB05 17.4 · IC025 +4.0 3/3 methods agree vs other NSAIDs: PRR 6.7 (5.9–7.5) | Not in label — unassessed | serious n=282 | not reported in cached trials |
| Peripheral venous disease | 702 | 22.4 20.6–24.3ROR 22.5 · calibrated p 0.001 ✓ | 18.6 EB05 17.4 · IC025 +4.1 3/3 methods agree vs other NSAIDs: PRR 4.3 (4.0–4.7) | Not in label — unassessed | serious n=699 · ♀ 100% (drug 65%) · 92% clinician | NCT00346216: 1/7,992 (0.0%) on Ibuprofen Capsule (serious AE) |
| Synovitis | 3,101 | 21.8 21.0–22.6ROR 22.1 · calibrated p 0.001 ✓ | 18.2 EB05 17.6 · IC025 +4.1 3/3 methods agree vs other NSAIDs: PRR 4.8 (4.6–4.9) | Not in label — unassessed | serious PRR 15.0 · ♀ 95% (drug 65%) · 92% clinician | NCT00346216: 1/8,030 (0.0%) on Ibuprofen Capsule (serious AE) |
| Granuloma skin | 138 | 21.0 17.5–25.2ROR 21.0 · calibrated p 0.002 ✓ | 17.6 EB05 15.2 · IC025 +3.8 3/3 methods agree vs other NSAIDs: PRR 7.0 (5.9–8.4) | Not in label — unassessed | serious n=138 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Gastric ulcer perforation | 199 | 19.5 16.8–22.7ROR 19.5 · calibrated p 0.002 ✓ | 16.6 EB05 14.7 · IC025 +3.8 3/3 methods agree vs other NSAIDs: PRR 11.3 (9.7–13.2) | Labeled — boxed warning synonym match | serious n=199 · 100% clinician | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 167 | 19.3 16.3–22.7ROR 19.3 · calibrated p 0.002 ✓ | 16.4 EB05 14.4 · IC025 +3.7 3/3 methods agree vs other NSAIDs: PRR 6.9 (5.8–8.1) | Not in label — unassessed | serious n=167 | not reported in cached trials |
| Porphyria acute | 208 | 18.6 16.1–21.6ROR 18.6 · calibrated p 0.003 ✓ | 15.9 EB05 14.2 · IC025 +3.7 3/3 methods agree vs other NSAIDs: PRR 4.9 (4.2–5.6) | Not in label — unassessed | serious n=206 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Irritable bowel syndrome | 3,158 | 18.2 17.5–18.9ROR 18.5 · calibrated p 0.003 ✓ | 15.6 EB05 15.2 · IC025 +3.9 3/3 methods agree vs other NSAIDs: PRR 5.8 (5.6–6.0) | Not in label — unassessed | serious PRR 15.4 · ♀ 98% (drug 65%) | NCT00346216: 1/8,030 (0.0%) on Ibuprofen Capsule (serious AE) |
| Seronegative arthritis | 160 | 17.4 14.8–20.6ROR 17.5 · calibrated p 0.004 ✓ | 15.0 EB05 13.2 · IC025 +3.6 3/3 methods agree vs other NSAIDs: PRR 4.9 (4.1–5.7) | Likely indication confounding shares a disease stem with the indications wording | serious n=160 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Renal tubular acidosis | 290 | 16.0 14.2–18.1ROR 16.1 · calibrated p 0.005 ✓ | 14.0 EB05 12.7 · IC025 +3.6 3/3 methods agree vs other NSAIDs: PRR 11.8 (10.3–13.4) | Not in label — unassessed | serious n=288 · 100% clinician | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 2,865 | 15.4 14.8–16.0ROR 15.6 · calibrated p 0.006 ✓ | 13.5 EB05 13.1 · IC025 +3.7 3/3 methods agree vs other NSAIDs: PRR 5.2 (5.0–5.4) | Labeled (related wording) related wording | serious PRR 15.1 · ♀ 98% (drug 65%) | not reported in cached trials |
| Fixed eruption | 214 | 15.2 13.1–17.5ROR 15.2 · calibrated p 0.007 ✓ | 13.3 EB05 11.9 · IC025 +3.5 3/3 methods agree vs other NSAIDs: PRR 11.4 (9.8–13.2) | Labeled (related wording) related wording | serious n=189 · ♀ 0% (drug 65%) · 100% clinician | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 164 | 14.0 11.9–16.4ROR 14.0 · calibrated p 0.010 ✓ | 12.4 EB05 10.8 · IC025 +3.3 3/3 methods agree vs other NSAIDs: PRR 14.3 (12.0–17.0) | Not in label — unassessed | serious n=161 · ♀ 0% (drug 65%) | not reported in cached trials |
| Drug tolerance decreased | 324 | 13.7 12.2–15.4ROR 13.7 · calibrated p 0.010 ✓ | 12.2 EB05 11.1 · IC025 +3.4 3/3 methods agree vs other NSAIDs: PRR 4.8 (4.3–5.4) | Not in label — unassessed | serious n=314 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Anaphylaxis / angioedema | 4,841 | 4.24.1–4.3 | signal |
| Severe cutaneous reaction | 2,764 | 4.03.9–4.2 | signal |
| Gi bleeding | 5,625 | 3.33.2–3.4 | signal |
| Suicidality | 7,527 | 3.33.2–3.4 | signal |
| Liver injury | 8,914 | 3.23.1–3.3 | signal |
| Tendon disorder | 1,066 | 3.02.8–3.2 | signal |
| Kidney injury | 11,973 | 2.82.8–2.9 | signal |
| Depression | 5,733 | 2.22.1–2.2 | signal |
| Venous thromboembolism | 3,759 | 1.91.8–1.9 | raised |
| Pancreatitis | 1,303 | 1.71.6–1.8 | raised |
| Serious infection | 12,396 | 1.71.7–1.7 | raised |
| Hyponatraemia | 1,198 | 1.61.5–1.7 | raised |
| Rhabdomyolysis / myopathy | 1,193 | 1.61.5–1.7 | raised |
| Interstitial lung disease | 1,371 | 1.51.4–1.6 | raised |
| Anaemia | 4,272 | 1.51.5–1.6 | raised |
| Fall / fracture | 4,876 | 1.41.3–1.4 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Ibuprofen Capsule as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (6 of 40 signal terms matched).
- NCT00346216 — Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen (N=24081, PHASE4; 1238 AE terms posted; arms: Celecoxib; Ibuprofen; Naproxen)
- NCT01789606 — Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet (N=1083, PHASE3; 60 AE terms posted; arms: Compliance Arm)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 15,699 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.499 | 1.3 EB05 1.2 · IC025 +0.3 vs other NSAIDs: PRR 4.0 (3.9–4.0) | Reporting / coding artifact | age-adj. PRR 1.3 · serious PRR 1.8 | not reported in cached trials |
| Pain | 15,060 | 2.6 2.6–2.7ROR 2.8 · calibrated p 0.709 | 2.6 EB05 2.6 · IC025 +1.3 3/3 methods agree vs other NSAIDs: PRR 4.8 (4.7–4.8) | Labeled — boxed warning exact term | age-adj. PRR 2.7 · serious PRR 2.7 | NCT00346216: 7/7,992 (0.1%) on Ibuprofen Capsule (serious AE) |
| Fatigue (tiredness) | 14,474 | 2.0 2.0–2.0ROR 2.1 · calibrated p 0.980 | 2.0 EB05 1.9 · IC025 +1.0 vs other NSAIDs: PRR 4.3 (4.3–4.4) | Not in label — unassessed | age-adj. PRR 1.8 · serious PRR 2.2 | NCT00346216: 2/7,992 (0.0%) on Ibuprofen Capsule (serious AE) |
| Nausea | 13,506 | 1.8 1.8–1.9ROR 1.9 · calibrated p 0.879 | 1.8 EB05 1.8 · IC025 +0.8 vs other NSAIDs: PRR 4.4 (4.4–4.5) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.0 | NCT00346216: 3/7,992 (0.0%) on Ibuprofen Capsule (serious AE) |
| Headache | 12,089 | 2.1 2.0–2.1ROR 2.1 · calibrated p 0.986 | 2.0 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other NSAIDs: PRR 4.6 (4.5–4.6) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 2.3 | NCT00346216: 6/7,992 (0.1%) on Ibuprofen Capsule (serious AE) |
| Arthralgia (joint pain) | 10,921 | 2.8 2.8–2.9ROR 2.9 · calibrated p 0.645 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree vs other NSAIDs: PRR 4.5 (4.4–4.5) | Not in label — unassessed | age-adj. PRR 2.4 · serious PRR 3.3 | NCT00346216: 33/7,992 (0.4%) on Ibuprofen Capsule (serious AE) |
| Dyspnoea (shortness of breath) | 10,529 | 2.0 2.0–2.0ROR 2.0 · calibrated p 0.967 | 2.0 EB05 1.9 · IC025 +0.9 vs other NSAIDs: PRR 4.3 (4.3–4.4) | Not in label — unassessed | age-adj. PRR 1.8 · serious PRR 1.9 | NCT00346216: 24/7,992 (0.3%) on Ibuprofen Capsule (serious AE) |
| Vomiting | 9,974 | 2.3 2.2–2.3ROR 2.3 · calibrated p 0.882 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other NSAIDs: PRR 4.7 (4.7–4.8) | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 2.2 | NCT00346216: 7/7,992 (0.1%) on Ibuprofen Capsule (serious AE) |
| Diarrhoea (diarrhea) | 9,701 | 1.6 1.6–1.6ROR 1.6 · calibrated p 0.729 | 1.6 EB05 1.6 · IC025 +0.6 vs other NSAIDs: PRR 4.0 (3.9–4.1) | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 1.7 | NCT00346216: 8/7,992 (0.1%) on Ibuprofen Capsule (serious AE) |
| Rash | 9,031 | 2.2 2.2–2.3ROR 2.3 · calibrated p 0.909 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other NSAIDs: PRR 4.8 (4.7–4.9) | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 3.1 | NCT00346216: 1/8,030 (0.0%) on Ibuprofen Capsule (serious AE) |
| Off label use (used outside approved label) | 8,567 | 1.0 1.0–1.1ROR 1.0 · calibrated p 0.337 | 1.0 EB05 1.0 · IC025 +0.0 vs other NSAIDs: PRR 3.6 (3.6–3.7) | Reporting / coding artifact | age-adj. PRR 0.9 · serious PRR 1.2 | not reported in cached trials |
| Dizziness | 8,172 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.818 | 1.7 EB05 1.7 · IC025 +0.8 vs other NSAIDs: PRR 4.0 (3.9–4.1) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 1.8 | NCT00346216: 5/7,992 (0.1%) on Ibuprofen Capsule (serious AE) |
| Pruritus (itching) | 7,913 | 2.2 2.2–2.3ROR 2.3 · calibrated p 0.907 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other NSAIDs: PRR 4.9 (4.8–5.0) | Labeled adverse reaction exact term | age-adj. PRR 1.8 · serious PRR 3.3 | NCT00346216: 1/7,933 (0.0%) on Ibuprofen Capsule (serious AE) |
| Pyrexia (fever) | 7,886 | 2.4 2.4–2.5ROR 2.5 · calibrated p 0.812 | 2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other NSAIDs: PRR 4.9 (4.8–5.0) | Labeled (related wording) related wording | age-adj. PRR 1.9 · serious PRR 2.1 | NCT00346216: 4/7,992 (0.1%) on Ibuprofen Capsule (serious AE) |
| Acute kidney injury (sudden kidney damage) | 6,622 | 4.8 4.6–4.9ROR 4.9 · calibrated p 0.246 | 4.6 EB05 4.5 · IC025 +2.2 3/3 methods agree vs other NSAIDs: PRR 5.6 (5.4–5.7) | Labeled (related wording) related wording | age-adj. PRR 3.9 · serious PRR 3.6 | NCT00346216: 39/7,992 (0.5%) on Ibuprofen Capsule (serious AE) |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Nsaid exacerbated respiratory disease — n=172, PRR 99.9
- Deep vein thrombosis postoperative — n=797, PRR 72.3
- Lupus vulgaris — n=431, PRR 59.9
- Muscle injury — n=2,935, PRR 58.7
- Subcutaneous drug absorption impaired — n=193, PRR 57.8
- Adjustment disorder with depressed mood — n=689, PRR 54.7
- Aspirin-exacerbated respiratory disease — n=196, PRR 48.1
- Dislocation of vertebra — n=619, PRR 40.6
- Folliculitis — n=2,860, PRR 40.3
- Helicobacter infection — n=2,811, PRR 40.1
✓ A hand-written Bradford Hill causality assessment exists for this drug: Ibuprofen (NSAIDs) ↔ Gastrointestinal bleeding.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ibuprofen Capsule?
In FDA FAERS, the most frequently co-reported reaction terms for Ibuprofen Capsule are pain, fatigue, nausea, headache, arthralgia, dyspnoea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ibuprofen Capsule have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see WARNINGS and PRECAUTIONS ].
Do FAERS signals prove that Ibuprofen Capsule causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 0387bfaa-daca-48ec-b718-0216a848c16a, effective 20260710; matched on
openfda.generic_name.exact:"IBUPROFEN" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 3672 description (ChEBI)
- Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,174 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
IBUPROFEN, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.